Catalog Number 1945 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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Customer reported the device leaked during use.It was reported "there was no medical intervention because it did not characterize an adverse event.The product did not mix and was replaced." no patient harm reported.
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Event Description
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Customer reported the device leaked during use.It was reported "there was no medical intervention because it did not characterize an adverse event.The product did not mix and was replaced." no patient harm reported.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the tubing and connector were assembled incorrectly.No other issues were found.The device history record of batch number 74k1801350 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the visual inspection test of the sample received, the complaint is confirmed.A non-conformance has been opened to address this issue.
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Search Alerts/Recalls
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